Arnold Ventures submitted comments to the Centers for Medicare and Medicaid Services (CMS) on the proposed rule to codify Medicare Drug Price Negotiation Program policies for Initial Price Applicability Year 2029 and later. The letter outlines AV’s support and recommendations for portions of the proposed rule.
In particular, AV supports the CMS policy for aggregating fixed combination products for the purpose of determining qualifying single source drugs for negotiation, including the proposed modification in the rule, which would strengthen the program’s integrity.
Additionally, the letter makes two recommendations to CMS. AV recommends that CMS incorporate all price concessions from manufacturers to Part D plans, including those granted under the manufacturer discount program, when estimating the ceiling price that is based on the net price to Part D plans. AV also recommends that if the non-FAMP ceiling price falls below the temporary floor for certain small biotech drugs, CMS should simply raise the ceiling to be equal to the Temporary Floor for Small Biotech Drugs instead of restricting the ceiling calculation to the non-FAMP in effect the year before the drug’s selection into negotiations.
